The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

NCT01610193 | Unknown DMC

• 1 other identifier: PSP_Appendix
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 2

Brief Summary

PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and the gut. There is evidence from experimental and clinical trials that the levels of PSP in the blood rise in the presence of inflammation or infection. What is not yet well known about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.

Conditions

Appendicitis; Abdominal Pain; Abdominal Sepsis

Keywords

Pancreatic Stone Protein; Abdominal pain; Acute appendicitis; Alvarado score; Appendectomy; Sensitivity and specificity

Outcome Measures

Primary Outcomes (1)

• Accuracy of PSP in diagnosing appendicitis

  ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis

  1 day

Secondary Outcomes (5)

• Accuracy of CRP in diagnosing appendicitis

  1 day

• Accuracy of WCC in diagnosing appendicitis

  1 day

• Accuracy of the "Alvarado Score" in diagnosis appendicitis

  1 day

• Accuracy of USS in diagnosing appendicitis

  1 day

• Accuracy of CT in diagnosing appendicitis

  1 day

Other Outcomes (1)

• Independent predictors of appendicitis

  1 day

Study Arms (1)

Right sided abdominal pain

Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.

Procedure: Appendicectomy

Interventions

Appendicectomy PROCEDURE

Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.

Also known as: Appendectomy or appendisectomy

Right sided abdominal pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients that will present at the emergency department with abdominal pain and a clinical suspicion of acute appendicitis.

You may qualify if:

• Age \>18 years of age (subject to the current ethics approval protocol, may change)
• Clinical suspicion of appendicitis as the primary or differential diagnoses
• Patients able to provide informed consent

You may not qualify if:

• Age \<18 years of age (subject to the current ethics approval protocol, may change)
• Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis
• Pregnancy
• Patients with impaired consciousness
• Patients not able to provide informed consent
• Patients that will receive an appendicectomy as part of another elective procedure

Sponsors & Collaborators

• University of Zurich: lead
• Laikο General Hospital, Athens: collaborator
• University of Athens: collaborator
• Kantonsspital Münsterlingen: collaborator

Study Sites (2)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

University Hospital Zurich, Department of Surgery

Zurich, CH-8091, Switzerland

NOT YET RECRUITING

Related Publications (9)

• Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.

  PMID: 3963537 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.

  PMID: 21835904 BACKGROUND

• Keel M, Harter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6.

  PMID: 19325491 BACKGROUND

• Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.

  PMID: 16360171 BACKGROUND

• Bimmler D, Graf R, Scheele GA, Frick TW. Pancreatic stone protein (lithostathine), a physiologically relevant pancreatic calcium carbonate crystal inhibitor? J Biol Chem. 1997 Jan 31;272(5):3073-82. doi: 10.1074/jbc.272.5.3073.

  PMID: 9006958 BACKGROUND

• Planas R, Pujol-Autonell I, Ruiz E, Montraveta M, Cabre E, Lucas-Martin A, Pujol-Borrell R, Martinez-Caceres E, Vives-Pi M. Regenerating gene Ialpha is a biomarker for diagnosis and monitoring of celiac disease: a preliminary study. Transl Res. 2011 Sep;158(3):140-5. doi: 10.1016/j.trsl.2011.04.004. Epub 2011 May 30.

  PMID: 21867979 BACKGROUND

• Jin CX, Hayakawa T, Ko SB, Ishiguro H, Kitagawa M. Pancreatic stone protein/regenerating protein family in pancreatic and gastrointestinal diseases. Intern Med. 2011;50(15):1507-16. doi: 10.2169/internalmedicine.50.5362. Epub 2011 Aug 1.

  PMID: 21804274 BACKGROUND

• Tschuor C, Raptis DA, Limani P, Bachler T, Oberkofler CE, Breitenstein S, Graf R. The value of pancreatic stone protein in predicting acute appendicitis in patients presenting at the emergency department with abdominal pain. BMC Gastroenterol. 2012 Oct 25;12:154. doi: 10.1186/1471-230X-12-154.

  PMID: 23098130 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and serum or plasma of 245 patients.

MeSH Terms

Conditions

Appendicitis; Abdominal Pain; Intraabdominal Infections; Hypersensitivity

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Immune System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Dimitri A Raptis, MD, MSc

  University Hospital Zurich, Department of Surgery

  PRINCIPAL INVESTIGATOR

• Rolf Graf, PhD

  University Hospital Zurich, Department of Surgery

  STUDY CHAIR

Central Study Contacts

Dimitri A Raptis, MD, MSc

CONTACT

+41798820542; dimitri.raptis@usz.ch

Rolf Graf, PhD

CONTACT

+41442553041; rolf.graf@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 23, 2013

Record last verified: 2013-08

Locations

CH (2)